510(k) Report

Devices descending from K163234

12 later devices reach Biograph mMR with syngo MR E11P system software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253963Cubresa BrainPETCubresa, Inc.20260—
+1K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.20201Class I
+1K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+1K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.20170—
+2K253023BIOGRAPH OneSiemens Healthineers AG20260—
+2K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+3K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+4K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+5K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+6K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+7K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+7K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—